Primary autonomic disorders are a group of diseases that usually begin in adulthood with the inability to stand because of dizziness, lightheadedness and fainting. Symptoms are the result of a dysfunction in the autonomic nerves that regulate blood pressure and heart rate, and are either related to the accumulation of abnormal protein deposits and a primary neurodegenerative process (like Parkinson's disease, pure autonomic failure, dementia with Lewy bodies and multiple system atrophy), secondary to genetic abnormalities (dopamine-beta-hydroxylase deficiency), an autoimmune process (autoimmune ganglionopathy), or because of a direct injury to the nerves involved in buffering blood pressure fluctuations (acquired baroreflex failure). Furthermore, there are a group disorders that are characterized by disabling orthostatic intolerance such as the postural tachycardia syndrome (POTS) in which the underlying cause is unclear. The purpose of this study is to characterize the clinical features and biological markers of the different types of primary autonomic disorders and better understand how these disorders evolve over time. The study will involve a series of follow-up visits to Centers participating in the Autonomic Disorders Consortium.

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:

To create a database of primary autonomic disorders that will serve as a phenotyping core. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

We will create an enrollment database of patients with primary autonomic disorders. All patients will have standardized phenotyping evaluations that will combine clinical, physiological and biochemical strategies to characterize complex autonomic phenotypes, both known and still undiscovered.

Secondary Outcome Measures:

To define the natural history of neurogenic orthostatic hypotension and identify predictive biomarkers of autonomic disorders [ Time Frame: 5 years ] [ Designated as safety issue: No ]

We will map the natural history of primary autonomic failure and test the hypothesis that pure autonomic failure (PAF) is a neurodegenerative synucleinopathy that remains confined to the autonomic nervous system. We will also identify biomarkers that can distinguish patients with PAF from those with early (i.e., "pre-motor") MSA, PD, DLB or autonomic failure as a result of another disorder.

Primary autonomic disorders are a group of diseases that usually begin in adulthood with the inability to stand because of dizziness, lightheadedness and fainting. Symptoms are the result of a dysfunction in the autonomic nerves that regulate blood pressure and heart rate, and are either related to the accumulation of abnormal protein deposits and a primary neurodegenerative process (like Parkinson's disease, pure autonomic failure, dementia with Lewy bodies and multiple system atrophy), secondary to genetic abnormalities (dopamine-beta-hydroxylase deficiency), an autoimmune process (autoimmune ganglionopathy), or because of a direct injury to the nerves involved in buffering blood pressure fluctuations (acquired baroreflex failure).

Criteria

Inclusion Criteria:

Both male and female patients will be included

Aged 18 or over

Referred to any of the participating consortium sites with orthostatic intolerance, defined as symptoms of dizziness or lightheadedness in the standing position that disappear when supine.

Exclusion Criteria:

Diabetes according to the American Diabetes Association criteria

Congestive heart failure

Lupus or other collagen vascular disease

Systemic illness thought to be responsible for the orthostatic intolerance

Drug-induced orthostatic hypotension (i.e., the use of alpha-blockers, diuretics, tricyclic antidepressants or others thought by the investigator to play an important role in the patient's orthostatic hypotension)

Isolated vasovagal syncope

Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study.

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01799915